Post-Approval Study of MelaFind

MELA Sciences, Inc.487 enrolled

Overview

The purpose of this study is to collect data to describe the real-world use and safety and effectiveness of MelaFind® in a post-approval clinical setting.

The primary objective of this study to test the hypothesis that, among eligible and evaluable lesions with central histological reference standard status melanoma or high-grade lesion, the relative sensitivity ρ comparing enrolling dermatologists after MelaFind use with enrolling dermatologists if MelaFind were not available is greater than 110%. This represents a clinically meaningful increase in sensitivity. The secondary objectives of this study are to evaluate real-world use and safety and effectiveness of MelaFind in a clinical setting.

Study Type

OBSERVATIONAL

Enrollment

487

Conditions

Melanoma

Interventions

MelaFindDEVICE

The device is used when a dermatologist chooses to obtain additional information on atypical skin lesions for a decision to biopsy.

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * The lesion is pigmented (i.e., melanin, keratin, blood) * Clinical management of the lesion by the examining dermatologist is either biopsy of the lesion in toto, or 3-month follow-up of the lesion * The diameter of the pigmented area is between 2 and 22 millimeters * The lesion is accessible to the MelaFind hand-held imaging device * The patient, or a legally authorized representative, has consented to participate in the study and has signed the Informed Consent Form Exclusion Criteria: * The patient has a known allergy to isopropyl alcohol * The lesion has been previously biopsied, excised, or traumatized * The skin is not intact (e.g., open sores, ulcers, bleeding) * The lesion is within 1 cm of the eye * The lesion is on mucosal surfaces (e.g., lips, genitals) * The lesion is on palmar hands * The lesion is on plantar feet * The lesion is on or under nails * The lesion is located on or in an area of visible scarring * The lesion contains foreign matter (e.g., tattoo, splinter, marker)

Locations (6)

AboutSkin Dermatology and DermSurgery

Englewood, Colorado, United States

Dermatology Associates of Tallahassee

Tallahassee, Florida, United States

The Johns Hopkins University

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Relative sensitivity comparing enrolling dermatologists after MelaFind use with enrolling dermatoligsts if MelaFind were not available

Time frame: 6 years

Secondary Outcomes

To describe characteristics of patients and lesions with MelaFind, the experience of using MelaFind, distribution of test results, and details on biopsied lesions.

Time frame: 6 years

Data from ClinicalTrials.gov

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